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Rise of multi-site trials prompts FDA guidance on IRBs

By Nick Taylor , 14-Jan-2010

The FDA has issued draft guidance detailing the information that should be submitted to an IRB as part of the continuing review of a clinical trial, with particular emphasis placed on the rise of multi-site studies.

Regulations for institutional review boards (IRB) were first issued by the US Food and Drug Administration (FDA) in 1981 when most trials were conducted at a single site.

Since then multi-site trials, conducted around the world, have become commonplace. To ensure it is relevant to modern-day clinical trials the FDA has issued new guidance on continuing review for IRBs, clinical investigators and sponsors .

For multi-site studies the FDA recommends that sponsors provide IRBs directly with information from the whole study, data monitoring committee (DMC) reports and other information relevant to continuing review.

The FDA places these responsibilities with the sponsor because of their “unique position of having information across all study sites, interim assessments by DMCs and safety information”.

Submissions for continuing review can be made to an IRB other than the one that conducted the initial review. However, the FDA advises that the IRB which performed the initial review may be best placed to conduct later evaluations because of its familiarity with the trial.

When reviewing multi-site trials a centralised (CIRB) review process can be adopted. This is applicable to trials which have different IRBs assigned to some of the sites.

By cooperating in this manner the FDA believes IRBs can reduce or eliminate duplication of tasks and improve the consistency of the continuing review process.

The guidance also gives a list of information it recommends IRBs should request from sponsors. Much of this is often included in the annual reports prepared by study sponsors and in these cases a separate document does not have to be prepared.

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